- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07762976
Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma
Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma: A Prospective Single-center Phase II Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Xiayun He, MD
- Telefonnummer: +86021-64175590-81412
- E-post: hexiayun1962@163.com
Studera Kontakt Backup
- Namn: Fen Xue, MD
- Telefonnummer: +8618916882304
- E-post: dr_fenxue@163.com
Studieorter
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200032
- Rekrytering
- Fudan Universtiy Shanghai Cancer Center
-
Kontakt:
- Xiayun He, MD
- Telefonnummer: +86021-64175590-81412
- E-post: hexiayun1962@163.com
-
Kontakt:
- Fen Xue, MD
- E-post: dr_fenxue@163.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Age: 18 - 65 years old
- Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing squamous cell carcinoma.
- AJCC/UICC 9th edition stage II - III; excluding patients with T3N0M0 (only posterior pharyngeal lymph node metastasis) and T3N1M0.
- Baseline plasma EBV-DNA > 0, and able to complete dynamic monitoring according to the protocol.
- ECOG 0 - 1.
- Main organ functions meet the requirements: neutrophils ≥ 2.0×10^9/L, platelets ≥ 100×10^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 1.5×ULN, total bilirubin ≤ 1.5×ULN; creatinine clearance rate ≥ 60 mL/min.
- Signed informed consent form, willing to complete the study according to the protocol.
Exclusion Criteria:
- Clinical or imaging examinations have confirmed distant metastasis.
- Before the diagnosis of nasopharyngeal carcinoma, the patient had received chemotherapy, targeted therapy, or immunotherapy, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).
- Has an active autoimmune disease, but the following conditions are excluded: type 1 diabetes, hypothyroidism receiving replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia).
- Active hepatitis B with poor control of HBV DNA, active hepatitis C, HIV infection or uncontrolled infection.
- Within 4 weeks before signing the informed consent form, the patient had used systemic glucocorticoids (equivalent to prednisone dose > 10mg/day) or other immunosuppressive treatments; if the patient's systemic glucocorticoid dose is equivalent to prednisone ≤ 10mg/day or only uses inhaled or topical glucocorticoids, participation is allowed.
- Has a history of active tuberculosis (Mycobacterium tuberculosis infection) in the past year; if active tuberculosis has been fully treated and has been over one year ago, participation is allowed.
- Has a history of interstitial lung disease.
- Has received live vaccines within 4 weeks before signing the informed consent form, or is about to receive live vaccines in the near future.
- Pregnant or lactating women, or reproductive-aged subjects who do not agree to take effective contraceptive measures.
- Has a history of other malignant tumors within the past 5 years, but the following situations are excluded: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc.
- Cannot take oral medications or have a known severe allergy to capecitabine, tislelizumab, or cisplatin/gemcitabine.
- Has any other conditions, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illness or family/social factors, which the investigator believes may affect the patient's ability to sign the informed consent form, cooperate and participate in the study, or interfere with the interpretation of the study results.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Low-risk group
Patient treated with induction chemotherapy(Gemcitabine 1000 mg/m², administered intravenously on days 1 and 8; Cisplatin 80 mg/m², administered intravenously on day 1 or in 3 divided doses; 1 cycle every 21 days, for a total of 2 cycles), followed by IMRT. Then received risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy. Clinical follow-up and surveillance only for low-risk group |
Clinical follow-up and surveillance only.
|
|
Experimentell: Medium-risk group
Capecitabine for medium-risk group after IMRT
|
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks.
Treatment duration: 8 cycles
Tislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks. Treatment duration: 8 cycles(Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles) |
|
Experimentell: High-risk group
Tislelizumab and Capecitabine for high-risk group after IMRT
|
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks.
Treatment duration: 8 cycles
Tislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks. Treatment duration: 8 cycles(Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles) |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
2-year Failure Free Survival, 2-y FFS
Tidsram: 2 years
|
calculated from the date of diagnosis of NPC to the date of tumor recurrence, progression, distant metastasis or death due to any cause,whichever comes earlier.
|
2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overal Survival,OS
Tidsram: 2 years
|
calculated from the date of diagnosis of NPC to the date of death from any cause
|
2 years
|
|
Locoregionally Failure Free Survival,LRFFS
Tidsram: 2 years
|
calculated from the date of diagnosis of NPC to the date of locoregional failure or date of death from any cause, whichever comes earlier.
|
2 years
|
|
Distant failure free survival, DFFS
Tidsram: 2 years
|
calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.
|
2 years
|
|
Adverse effects (AE)
Tidsram: during and after treatment (up to 2 years)
|
during and after treatment (up to 2 years)
|
|
|
Objective Response Rate
Tidsram: at the end of, 3 months and 6 months after IMRT
|
at the end of, 3 months and 6 months after IMRT
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Xiayun He, Fudan University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Stomatogena sjukdomar
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Neoplasmer i huvud och hals
- Neoplasmer, körtel och epitel
- Carcinom
- Otorhinolaryngologiska sjukdomar
- Faryngeala neoplasmer
- Otorhinolaryngologiska neoplasmer
- Nasofaryngeala sjukdomar
- Faryngeala sjukdomar
- Nasofaryngeala neoplasmer
- Nasofaryngealt karcinom
- Undersökningstekniker
- Metoder
- Terapeutik
- Narkotikabehandling
- Kombinerad modalitetsterapi
- Observation
- Kemoterapi, adjuvans
Andra studie-ID-nummer
- ADAPT-01
Plan för individuella deltagardata (IPD)
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